Status:
TERMINATED
Coenzyme Q10 in Huntington's Disease (HD)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Conditions:
Huntington's Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q1...
Detailed Description
Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effectiv...
Eligibility Criteria
Inclusion
- To be eligible for enrollment into this study, subjects must meet the following eligibility criteria within 28 days prior to randomization:
- Subjects must have clinical features of HD and a confirmed family history of HD, OR a CAG repeat expansion ≥ 36.
- TFC \> 9.
- Must be ambulatory and not require skilled nursing care.
- Age ≥ 16 years.
- Women must not be able to become pregnant (e.g., post menopausal, surgically sterile or using adequate birth control methods for the duration of the study).
- If psychotropic medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants), they must be at a stable dosage for four weeks prior to randomization and should be maintained at a constant dosage throughout the study, as possible. (Note: stable dosing of tetrabenazine is allowable.) Any changes to these medications mandated by clinical conditions will be systematically recorded and the subject will be permitted to remain in the trial.
- Able to give informed consent and comply with trial procedures
- Able to take oral medication.
- May be required to identify an informant or caregiver who will be willing and able to supervise the daily dosing of study medications and to maintain control of study medications in the home.
- A designated individual will be identified by the subject to participate in the ongoing consent process should the subject's cognitive capacity to consent become compromised during participation in the study.
Exclusion
- History or known sensitivity of intolerability to CoQ.
- Exposure to any investigational drug within 30 days of the Baseline visit.
- Clinical evidence of unstable medical illness in the investigator's judgment.
- Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression or suicidal ideation within 90 days of the Baseline visit.
- Substance (alcohol or drug) abuse within one year of the Baseline visit.
- Women who are pregnant or breastfeeding.
- Use of supplemental coenzyme Q10 within 30 days prior to the Baseline visit
- Clinically serious abnormalities in the screening laboratory studies (Screening creatinine greater than 2.0, alanine aminotransferase (ALT) or total bilirubin greater than 3 times the upper limit of normal, absolute neutrophil count of ≤1000/ul, platelet concentration of \<100,000/ul, hematocrit level of \<33 for female or \<35 for male, or coagulation tests \> 1.5 time upper limit of normal).
- Known allergy to FD\&C yellow #5 or any other ingredient in the study drug (active and placebo)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
609 Patients enrolled
Trial Details
Trial ID
NCT00608881
Start Date
March 1 2008
End Date
May 1 2015
Last Update
March 30 2016
Active Locations (49)
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1
University of Alabama At Birmingham, Pediatric Neurology Childrens, Harbor Bldg Suite 314, 1600 7Th Avenue South
Birmingham, Alabama, United States, 35233-1711
2
Mayo Clinic Arizona, 13400 East Shea Boulevard, Csu-Cp21B
Scottsdale, Arizona, United States, 85259
3
WASHINGTON REGIONAL MEDICAL CENTER, 3215 N. North Hills Blvd
Fayetteville, Arkansas, United States, 72703
4
University of California Irvine, Department of Neurology, 100 Irvine Hall
Irvine, California, United States, 92697-4275